FreeStyle InsuLinx Blood Glucose Monitoring System


  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
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  • Modèle / numéro de série
    Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    FreeStyle InsuLinx Blood Glucose Monitoring System: || For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. || Abbott Diabetes Care, Inc. || 1360 South Loop Road || Alameda, CA 94502 USA || The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
  • Manufacturer
  • Modèle / numéro de série
    71146-70 | 01S194F; 01S275F; 04R320F; 05R320F; 05R347F; 06R348F | all
  • Description du dispositif
    IVD: Home-use/point-of-care blood glucose monitoring system IVD
  • Manufacturer